To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
研究概览
简要总结
To investigate the molecular mechanism of traditional Chinese medicine constitution, the investigators proposed a randomized, double-blind, placebo-controlled, phase II trial to recruit 120 patients with nasopharyngeal cancer. Next generation sequencing, immune repertoire, gut microbiota, traditional Chinese medicine constitution and tongue diagnosis would be examined before/after 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy in this project. The correlation between different examinations would be analyzed to investigate the molecular mechanism of traditional Chinese medicine constitution. Disease survival, recurrence, and quality of life would be also followed up for two years to evaluate the benefit of Danggui BuxueTang.
详细描述
The basis for academic excellence is the interdisciplinary cooperation. The individualized medicine is the future trends, and the theory of body constitution is the most potential study for the individualized medicine and to research the process and prognosis of disease. Technique of next-generation sequencing (NGS) is also involved to comprehend to the mechanism of the prescriptions under the theory of body constitution.
The nasopharyngeal cancer is a Chinese-specific disease, and radiation therapy has remarkable effect. There are many studies proving that Traditional Chinese medication can relieve the side effect of radiation therapy. The study will combine next-generation sequencing and TCM diagnostic tool, and analyze the transformation of body constitution and the performance of genes related to radiation therapy. The results may reveal the molecular mechanism of TCM constitutions and the benefit of Danggui BuxueTang, and may be used for early screen and prevention to other cancers or diseases. Furthermore, it can help to develop the potential drugs.
The study plans to collect 120 cases within two years. The participants would be divided randomly to the experimental group and control group. The blood sample would be taken for next generation sequencing analysis before the radiation therapy, and after the radiation therapy combined with traditional Chinese medication. The result of samples would be compared with each other to identify "Qi deficiency gene" and "TCM effective gene".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological diagnosis of nasopharyngeal carcinoma stage II ~ IVa (AJCC eighth edition) preparing to receive concurrent chemoradiotherapy
排除标准
- •Pregnant or lactating women
- •ECOG PS (ECOG performance status) scores of over 2 points for each day's performance assessment
- •Take anticoagulants or antiplatelet agents such as aspirin, warfarin, etc.
- •Cannot accept routine treatment, or can not cooperate with the research program
研究组 & 干预措施
Danggui Buxue Tang group
Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
干预措施: Danggui Buxue Tang (Drug)
Placebo group
Use Placebo 5g/time, 3 times a day, for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
时间窗: The biomarker as assessed by Next-generation sequencing analysis, Change from baseline in the gene expression at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
Identification of biomarkers by next-generation sequencing analysis in nasopharyngeal cancer patients.
次要结局
- Survival rate(throughout the study, an average of 2 year)
- Tongue diagnosis(pre-treatment and after 16 weeks of treatment)
- The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer H&N35(Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.)
- Microbiota(pre-treatment and after 16 weeks of treatment)
- The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30(Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.)
- Immune repertoire(pre-treatment and after 16 weeks of treatment)
- Constitution in Chinese Medicine Questionnaire (CCMQ)(Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.)
- Disease recurrence(throughout the study, an average of 2 year)
- Next-generation sequencing(pre-treatment and after 16 weeks of treatment)